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NCT Number: NCT04287101

Post-acute Care for Patients With Hip Fracture

Background and purpose: Hip fracture, a common injury occurred in people aged over 50, may result in disability, poor quality of life, and higher care stress for their families. Aging population and growing number of hip fractures have increased medical expenses, so developed countries implemented post-acute care (PAC) to reduce acute hospitalization, and to improve the quality of care. PAC services can be delivered by hospital/facility-based and home-based services. Previous studies showed that both services could significantly improve patients' activities of daily living and quality of life, and reduce readmissions, long-term care and costs. Taiwan has implemented PAC plan for hip fractures since 2017, but relevant evidences are limited. Therefore, the purpose of this study is to analyze the efficacy and cost-effectiveness of PAC for patients with hip fractures.

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Key information

Conditions

Hip Fractures Activities of Daily Living Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei City Hospital

Taipei, Taiwan

About this study

Methods: This is a prospective cohort study which will recruit patients aged over 50 with hip fractures receiving surgical treatment in the Taipei City Hospital. They will be provided home-based PAC, hospital-based PAC, or no formal PAC based on the medical judgment and patients/families' willingness. The period of PAC will be two to three weeks after the acute hospitalization. Assessments include physical function (30 seconds sit to stand, Barthel index, and Harris Hip Score), numerical pain rating scale, EuroQol instrument (EQ-5D), Caregiver Strain Index, and using of medical resources. The assessments will be on the day before discharge from acute hospitalization, and on the discharge day from post-acute care. The follow-up assessment will be at 1, 3, 6, and 12 months after operation. The cost-effectiveness ratio will be defined as the New Taiwan dollars paid for 1-unit improvement of functional performance and quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 50
  • First hip fracture
  • Stable medical condition

Exclusion criteria

  • Hip fracture caused by major trauma or pathological condition
  • Multiple fractures
  • Severe physical disability before the hip fracture
  • Unable to cooperate with treatment
  • Further inpatient treatment

Treatment and study plan

Post-operative PT and OT

Other

Strengthening exercise, range-of-motion exercise, functional training, balance training, adjustment for assistive devices, adaptation and modification of the home environment, and patient/caregiver education

Primary outcomes

  1. 30-second sit to stand

    Time frame: within 1 year

    Ask participants to cross their arms at the chest, and to perform sit to stand as more as possible within 30 seconds. Measure the repetitions the participants do. Higher repetition indicates more strength of lower extremities.

  2. Activities of daily living Using the Barthel Index (BI)

    Time frame: within 1 year

    Using the Barthel Index (BI) to measure participants' activities of daily living. The self-care domain is self-report by the patient or their families. The mobility domain is observed by the assessor. The greater score indicates more independence.

  3. Functional performance of hip Using the Harris hip score (HHS)

    Time frame: within 1 year

    Using the Harris hip score (HHS) to measure participants' functional performance of hip. The pain domain is self-report by the patient. The function, deformity, and range of motion domain are observed by the assessor. The greater score indicates the better functional performance of hip.

  4. Pain intensity Using the numerical pain rating scale (NPRS)

    Time frame: within 1 year

    Using the numerical pain rating scale (NPRS) to measure participants' pain intensity. Ask participants to report their pain intensity with the 11-point scale (from 0 no pain to 10 worst possible pain).

  5. Quality of lives Using the EuroQol instrument (EQ-5D)

    Time frame: within 1 year

    Part 1: Ask participants to measure their mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the 3-point scale. The greater score indicates poor quality of life.

  6. Quality of lives Using the EuroQol instrument (EQ-5D)

    Time frame: within 1 year

    Part 2: Ask participants to measure their quality of life with a 20-cm visual analog scale. The greater score indicates a better quality of life.

  7. Caregiver strain Using the caregiver strain index (CSI)

    Time frame: within 1 year

    Using the caregiver strain index (CSI) to measure the strain of caregiver. Ask them to fill a 13-item questionnaire. Greater value indicates a higher strain.

  8. Medical Costs

    Time frame: within 1 year

    Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Official study title

Home-Based Integrated Post-Acute Care Program for Hip Fracture

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 27, 2020
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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